Sanofi SA · EURONEXT:SAN
Sanofi SA — Cowen Healthcare Conference 2011
27 slides from Sanofi SA's conference presentation, Mar 7, 2011
Slide 1: Cowen Healthcare Conference
March 7, 2011 Cowen Healthcare Conference Debasish Roychowdhury Senior Vice President ‐ Head of Global Oncology Division Boston
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains forward‐looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward‐looking statements are statements that are not historical facts. These statements include projections and estimates and their und
Slide 3: Our Strategy in Oncology is Based on Five Core Beliefs
3 Our Strategy in Oncology is Based on Five Core Beliefs Innovative treatments ‐ Proven substantial benefits are necessary Personalization ‐ Biomarkers, patient stratification tools, and targeted therapies Environment shaping ‐ Facilitating patient access to medicine Creation of more synergi
Slide 4: A New Approach to Developing Cancer Therapies
4 A New Approach to Developing Cancer Therapies From To Known targets Innovative targets Small molecules, biopharmaceuticals, nanodelivery Small molecules technologies, etc. First in class, best in class, differentiated by superior Best in class, differentiation classical efficacy and unmet need Com
Slide 5: Redefining our Oncology Presence
5 Redefining our Oncology Presence Recruiting Talent Streamlining Governance More than 100 new R&D centers reduced Creation of a new hires to the oncology from 11 to 3 Oncology Review division in 2010 Jevtana® NDA filed in Board to optimize and Many key hires have about 4 months of priorit
Slide 6: A Partner of Choice in Oncology
6 A Partner of Choice in Oncology Demonstrating our ability to add value Cutting‐edge technical expertise Investigating novel‐novel combinations Global execution and distribution Broad industrial platform, supply chain control Allowing partner to develop and prosper Enabling partner to
Slide 7: Emerging Markets – Executing a Local Approach
7 Emerging Markets – Executing a Local Approach Addressing regional differences in cancer Differences in incidence require epidemiology and biology regional approach to each indication Eloxatin®: Development of liver cancer indication for the Asia‐Pacific region China Estimated Cancer Incidence(
Slide 8: Maximizing the Emerging Markets Opportunity
8 Maximizing the Emerging Markets Opportunity New indications in China Taxotere® Relative Pricing(1) HRPC(2) in 2010 200 Advanced gastric cancer in 2012 Head and neck cancer in 2014 150 Expand the gastric cancer indication in 100 other Emerging Markets Pursue breast and prostate cancer 5
Slide 9: Leveraging Brand Equity
9 Leveraging Brand Equity Settlement of U.S. patent litigation Quarterly Sales (€m) Inventory workdown is progressing Preliminary Injunction granted on 353 February 16 by U.S. District Court Planned growth drivers in China: 193 Advanced HCC(1) in 2011 120 147 94 67 66 Liquid solution lau
Slide 10: Pipeline Rebuild Underway…February 2009 Before Portfolio Review
10 Pipeline Rebuild Underway…February 2009 Before Portfolio Review Phase I Phase II Phase III Marketed SAR3419 AVE 1642 Jevtana® Maytansin‐loaded anti‐CD19 mAb IGF1R mAb Taxane ‐ Tubulin inhibitor Taxotere® non‐Hodgkin’s lymphoma Breast Cancer docetaxel Prostate cancer aflibercept Eloxatin® SSR97225
Slide 11: Pipeline Rebuild Underway…December 2010 Rich and Strong Portfolio
11 Pipeline Rebuild Underway…December 2010 Rich and Strong Portfolio Phase I Phase II Phase III Marketed SAR3419* aflibercept* iniparib (BSI‐201) Taxotere® Maytansin‐loaded anti‐CD19 mAb VEGF‐Trap PARP inhibition docetaxel non‐Hodgkin’s lymphoma 1st line colorectal cancer mTNBC; NSCLC SAR153192* SAR
Slide 12: A New Cytotoxic Agent
12 A New Cytotoxic Agent The molecule New semi‐synthetic taxane Selected to overcome the emergence of taxane resistance(1) Mechanism of action Microtubule stabilizer(2) Prostate cancer Estimated new cases of prostate cancer in U.S. in 2009 = 192,000; Deaths 27,360 575,000 new cases of Pr
Slide 13: Launch Exceeding Expectations
13 Launch Exceeding Expectations FY 2010 sales of €82m exceeded Share of Patients in 2L+ mHRPC expectations 50% Reimbursement: 100% of Medicare carriers have made 40% 47.4% coverage decisions Minimal formulary restrictions by the vast majority of payors 30% Adopted into the NCCN(2) and EUA
Slide 14: Global Rollout in 2011
14 Global Rollout in 2011 Europe Planned launch schedule* Positive CHMP opinion in January 2011 EU roll‐out to start in Q2 2011 2010 2011 2012 380,000 new cases of prostate cancer annually About 25,000 to 30,000 cases are treated with chemotherapy Emerging Markets 2011: Brazil, South K
Slide 15: New Indications to Drive Future Growth
15 New Indications to Drive Future Growth Phase III study in first line prostate Jevtana® Development Opportunities cancer to begin enrolling Q1 2011 Faster Study to include about 1,100 mHRPC 2L mHRPC patients Primary endpoint: superiority of 2L SCLC Launch Timing cabazitaxel(1) vs. docetaxel
Slide 16: Iniparib: A Novel Anticancer Agent
Iniparib: A Novel Anticancer Agent Hypothesized Anti-Tumor Activity • Novel agent for treating tumors DNA with DNA repair defects Chemotherapy Damage Tumor • Small molecule: penetrates blood brain barrier(4) Chemotherapy Alone Chemotherapy Plus Iniparib • Expected to be combined safely PARP1 Facilit
Slide 17: Development of iniparib in mTNBC
Development of iniparib in mTNBC mTNBC Population • Phase II study in mTNBC • Overall Survival advantage without added toxicity(2) Breast Cancer • Phase III study in mTNBC • Primary goals were not met • Improvement in OS and PFS in 2L and 3L • Addition of BSI-201 did not significantly add to TNBC: 1
Slide 18: The Squamous Non-Small Cell Lung Cancer Opportunity
The Squamous Non-Small Cell Lung Cancer Opportunity Lung cancer deaths in the U.S.: • Squamous NSCLC biologically an 222,520 in 2010(4,5) attractive target • PARP1 upregulation(1) Lung cancer • Associated with basal-like phenotype, similar to TNBC(2,3) • Evidence of DNA repair impairment of BRCA pat
Slide 19: The Development of Iniparib in Lung Cancer
The Development of Iniparib in Lung Cancer Phase 3 Squamous Lung Cancer Study (International) Status STAGE STAGE IV IV • Initiated in US in March 2010 Gemcitabine Gemcitabine 1:1 Carboplatin Carboplatin Squamous Squamous • EU and ROW sites opened Cell Cell Lung Lung in Q4 2010 Cancer Cancer Gemcitab
Slide 20: Iniparib Development in Recurrent Ovarian Cancer
Iniparib Development in Recurrent Ovarian Cancer ~22K new diagnoses and ~15K High unmet need deaths in the U.S. in 20091 • Leading cause of death from gynecologic malignancy • Poor prognosis in advanced-stage disease Ovarian cancer Rationale and opportunity for iniparib • Preclinical activity of ini
Slide 21: Ongoing Phase 2 Studies in Recurrent Ovarian Cancer
Ongoing Phase 2 Studies in Recurrent Ovarian Cancer Phase 2 Platinum-Sensitive Ovarian Cancer (U.S.) Status Platinum-Sensitive • Initiated in Dec 2009 Platinum-Sensitive Recurrent Ovarian Recurrent Ovarian • Minimum 8 responses to Cancer Cancer proceed to Stage 2 Stage Stage 1 1 Stage Stage 2 2 Gem/
Slide 22: Aflibercept and Ombrabulin: Targeting Tumor Vasculature
22 Aflibercept and Ombrabulin A Commitment to Targeting Tumor Vasculature Avascular Angiogenic Vascularized phase switch tumor Tumor Late stage initiation Dissemination Antiangiogenic approach: Vascular‐disrupting approach: Prevention of new Disruption of vessel growth microvessels Chronic inhib
Slide 23: Aflibercept – Phase III Readouts in 2011 for Multiple Cancers
23 Aflibercept – Phase III Readouts in 2011 for Multiple Cancers Phase / Study Indication Design # of patients Data Expected 1st line metastatic Phase II 230 Final Analysis H2 2011 colorectal cancer AFFIRM 2nd line metastatic Phase III colorectal cancer 1200 Final analysis H1 2011 VELOUR + FOLFIRI (
Slide 24: Ombrabulin – Most Advanced Vascular Disrupting Agent
24 Ombrabulin – Most Advanced Vascular Disrupting Agent Good safety profile and encouraging signs of activity in Phase I/II(3) No QT prolongation(1) observed and very limited hematotoxicity Antitumor activity observed in combination with chemotherapy Complete Response observed in triple‐nega
Slide 25: Ombrabulin Development Program
25 Ombrabulin Development Program Shut Down of Tumor Blood Flow(1) Mechanism of action and preclinical data Baseline support development in most solid tumors High unmet medical need in soft‐tissue sarcoma after failure of standard therapy Orphan Drug status expected Around 30,000 patients in
Slide 26: Embracing External Innovation in Early Stage Development
26 Embracing External Innovation in Early Stage Development Selected Oncology Early Stage Projects Potentially first in class Novel anti‐ErbB3 mAb Highly potent and PI3K inhibitor Anticipated favorable selective JAK‐2 inhibitor Unique PI3K and safety profile to facilitate for myelofibrosis
Slide 27: Strong Commitment to Success
27 Strong Commitment to Success Built Delivered Established a nimble organization Two fast track designations Solid portfolio after rigorous pipeline Approval and launch of Jevtana review Improved life cycle management Leveraged internal expertise and embraced external innovation Reali